Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis
- Conditions
- Adenoviral Keratoconjunctivitis
- Interventions
- Registration Number
- NCT04376970
- Lead Sponsor
- Military Hospital of Tunis
- Brief Summary
Purpose:
To compare efficiency and tolerance between topical 0.5% cyclosporine A and fluorometholone in patients with subepithelial corneal infiltrates (SEIs).
Methods :
A prospective double-blind randomized study was conducted involving 72 eyes, 38 treated with topical fluorometholone and 34 eyes treated with cyclosporine A 0.5% eyedrops, having SEIs. Treatment was considered successful if there was reduction of SEIs and improvement in visual acuity (two snellen lines). Tolerance was mainly evaluated by Schirmer test, conjunctival hyperemia and burning sensation upon eyedrops instillation.
- Detailed Description
This study was performed on the 72 eyes of 51 patients who were referred to our clinics for epidemic keratoconjunctivitis (EKC).Diagnosis of EKC was based on the constellation of clinical features. The investigators conducted a double-blind randomized prospective parallel trial involving : 38 patients treated with topical fluorometholone and 34 eyes treated with cyclosporine A 0.5% eye drops. Cyclosporine A eye drops were prepared in Ricin oil by the pharmacy of Tunis Military Hospital. The sample size was measured by our research department, to obtain a conclusion of non-inferiority of cyclosporine A compared to fluorometholone in the chronic phase of EKC.
Duration of the whole regimen was six months. The study included an extra month after the end of the regimen. It was called " wash-out ". Patients who had less than one month of treatment or an uncontrolled treatment side effect or who presented a degenerative iron line were excluded from the rest of the regimen.The regimen was the same for both treatments in order to preserve the double-blind characteristic : 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.
Patients were examined on admission to the study and one month , three months, six months and seven months after the onset of treatment. The investigators followed a double-masked fashion in all the phases of the study.
Information gathered in M0 included basic demographic information (age and sex), medical and ophtalmological history, involved eye(s) and duration of symptoms in the acute episode. The investigators evaluated and recorded the interval of time between the onset of the infection and the beginning of the trial and called it " pretherapeutic period ". At each visit, SEIs were photo-documented, best corrected visual acuity (converted to mean logarithm of the minimum angle of resolution), spheric equivalent, SEIs number, intraocular pressure (with non contact tonometers), break-up time and Schimer test type 1 and cup/disc score were recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- patients having subepithelial infiltrates following epidemic keratoconjunctivites persisting for 14 days or more
- a past history of glaucoma or other anterior or posterior segment disease or surgery
- a chronic use of topical or systemic medications
- pregnancy,
- contact lens wearers,
- patients who couldn't attend at least two regimen visits
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyclosporine A group Cyclosporine A eye drops 0.5% This group included 34 patients treated with cyclosporine A 0.5% eye drops prepared in Ricin oil by the pharmacy of Tunis Military Hospital and prescribed 4 times a day for one month then 3 times a day for one month and 2 times a day for four months. Fluorometholone group FLUCON® This group included 38 patients treated with topical fluorometholone 0.1% (FLUCON®) 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.
- Primary Outcome Measures
Name Time Method Mean change from baseline in subepithelial infiltrates number day 0, Month 1, Month 3, Month 6, Month 7 The subepithelial infiltrates were counted at baseline and at each control visit.The mean change was then calculated between each two visits. Treatment was considrerd efficient if the subepithelial infiltrates decreased half the baseline number or completely disappeared.
Mean change from baseline in Schirmer type 1 value day 0, Month 1, Month 3, Month 6, Month 7 The Schirmer value was assessed without local anesthesia. Treatment was considered efficient with a good tolerance when the schirmer type 1 was superior than 5ml/5min.
- Secondary Outcome Measures
Name Time Method Mean change from baseline in best corrected visual acuity day 0, Month 1, Month 3, Month 6 A gain of two snellen lines from baseline was considered a mark of treatment efficiency.
Mean change from baseline in spheric equivalent day 0, Month 6 Spheric equivalent was calculated using an automatic refraction. An increase from baseline of 0.25 dioptries was considered a mark of treatment efficiency.
Mean change from baseline in clinical score day 0, Month 1, Month 3, Month 6 These subjective variables : (1) photophobia; (2) Foreign body sensation ; (3) Visual blurring ; (4) tearing and (5) ocular pain were evaluated according to their severity (0 indicated no ; 1, mild ; and 2, severe). The sum of these variables was calculated for each visit and called clinical score.
Overall satisfaction with treatment subjective evaluation: scale Month 7 For subjective evaluation of the treatment, patients were asked to evaluate in the seventh month their overall satisfaction with treatment on a scale of 0-10. 0 means no satisfaction with the treatment and 10 means an excellent satisfaction with the treatment.
Number of participants with burning sensation upon eyedrops instillation day 0, Month 1, Month 3, Month 6 Burning sensation upon eyedrops instillation was considered as a treatment intolerance mark.
Mean change from baseline in intraocular pressure day 0, Month 1, Month 3, Month 6 Intraocular pressure was measured with with non contact tonometers. An increase of 6 mmHg from baseline value was defined as a steroid-induced glaucoma.
Number of participants with appearance of lens opacification and corneal ulcer or superinfection up to six months Lens opacification and corneal ulcer or superinfection were considered as a mark of corticosteroid intolerance.
Trial Locations
- Locations (1)
Military Hospital of Tunis
🇹🇳Tunis, Illinois, Tunisia